Freyrinc

Freyr Solutions simplifies the entire UK MHRA medical-device registration process by verifying the manufacturers technical documentation and managing submissions on MHRA's Device Online Registration Portal . As a designated UK Responsible Person (UKRP), we liaise directly with the MHRA for device registrations, vigilance activities ensuring full MHRA post-market compliance. Our experts help you introduce your CE marked devices in UK, transition from CE to UKCA marking, manage and support vigilance activities, and keep you informed of the regulatory updates on a periodic basis so you can focus

Switzerland Medical Device Registration is a mandatory regulatory process for manufacturers and distributors who want to market medical devices in Switzerland. Although Switzerland is not part of the European Union, its medical device regulations are closely aligned with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with specific national requirements.

Product Complaints Management is a systematic process used by organizations to receive, document, investigate, resolve, and analyze customer complaints related to products. It ensures customer concerns are handled efficiently while meeting regulatory, quality, and compliance requirements. A well-defined complaints management system helps improve product quality, customer satisfaction, and brand credibility.

Post-Market Surveillance for Medical Devices is a critical regulatory and quality management process that ensures medical devices continue to perform safely and effectively after they are released into the market. It involves systematically collecting, analyzing, and evaluating data related to device performance, adverse events, customer feedback, and complaints to identify potential risks and take corrective actions.

Clinical Evaluation of Medical Devices is a systematic process used to assess the safety, performance, and clinical benefits of a medical device throughout its lifecycle. It is a regulatory requirement in many global markets, including the EU, UK, and other major jurisdictions, to demonstrate that a device meets applicable safety and performance standards before and after it enters the market.Clinical evaluation is a structured and ongoing assessment of clinical data related to a medical device. It involves collecting, analyzing, and interpreting relevant scientific and clinical information to

The FDA eSTAR Program (Electronic Submission Template and Resource) is a digital initiative launched by the U.S. Food and Drug Administration to modernize and standardize medical device regulatory submissions. Designed to simplify the preparation and review of applications such as 510(k), De Novo, and certain PMA submissions, eSTAR provides an interactive, structured template that guides applicants through the required content in a logical and user-friendly format.

Corrective and Preventive Action (CAPA) Management Services play a critical role in maintaining regulatory compliance, improving product quality, and ensuring continuous process improvement. CAPA is a systematic approach used to identify, investigate, and resolve quality issues while preventing their recurrence in the future. These services are especially essential for organizations operating in regulated industries such as medical devices, pharmaceuticals, biotechnology, and healthcare.